Federal/EPA Regulatory Policy

Lynn L. Bergeson, "EPA Eyes Perfluorinated Chemicals," Chemical Processing, February 11, 2015.

Between the late 1990s and early 2000s, the EPA identified potential issues presented by PFOS, a perfluorinated acid. Data showed PFOS to be present in low levels in humans and wildlife worldwide, and that PFOS appeared to be highly persistent. At the time, PFOS was used in industrial and consumer applications, including soil and stain repellant sprays, fire-fighting foams and semiconductor manufacture. Between 2000 and 2002, 3M Company, the principal domestic manufacturer of PFOS, voluntarily phased the chemical out of production. Working with industry, the EPA followed this action with a series of SNURs that were effectively intended to limit uses for which alternatives were not available. Several years later, similar concerns were raised with regard to PFOA, other LCPFACs, and other chemicals known as fluorinated telomers that potentially could degrade to PFOA in the environment. The EPA worked with the manufacturers and users of these chemicals to understand the risks and encourage development of alternatives. These efforts yielded the 2010/2015 PFOA Stewardship Program through which industry made and delivered on a series of commitments that, over time, made the current proposed SNUR possible. 

Lynn L. Bergeson, "EPA Proposes SNUR For Nonylphenols And Nonylphenol Ethoxylates," ABA Pesticides, Chemical Regulation, and Right-to-Know Committee Newsletter, December 2014.

On October 1, 2014, the U.S. Environmental Protection Agency (EPA) proposed a Significant New Use Rule (SNUR) for 15 related chemical substances commonly known as nonylphenols (NP) and nonylphenol ethoxylates (NPE). For 13 NPs and NPEs, EPA would designate any use as a "significant new use," and for two additional NPs, EPA would designate that any use other than use as an intermediate or use as an epoxy cure catalyst would constitute a “significant new use.” Persons subject to the SNURs would be required to notify EPA at least 90 days before they manufacture (including import) or process any of these 15 chemical substances for a significant new use.  The full ABA PCRRTK Newsletter is available online . 

Lynn L. Bergeson, "EPA Proposes New Rule for Toxic Chemicals," Chemical Processing, November 5, 2014.

On October 1, 2014, the U.S. Environmental Protection Agency (EPA) proposed a significant new use rule (SNUR) for 15 related chemical substances commonly known as nonylphenols (NP) and nonylphenol ethoxylates (NPE). These substances are recognized as persistent and toxic in the environment. This article discusses this important move.

Lynn L. Bergeson, "EPA Assessing Utility of Toxic Substances Control Act to Obtain Information on Hydraulic Fracturing," Environmental Quality Management, Fall 2014.

The United States Environmental Protection Agency (EPA) published in the May 19, 2014, Federal Register an advance notice of proposed rulemaking (ANPR) to seek comment on the information that should be reported or disclosed for hydraulic fracturing chemical substances and mixtures and the mechanism for obtaining this information. According to EPA, this mechanism could be regulatory (under Sections 8(a) and/or 8(d) of the Toxic Substances Control Act (TSCA)), voluntary, or a combination of both. It could include best management practices, third-party certification and collection, and incentives for disclosure of information.
 

Lynn L. Bergeson, "Misleading Recycled Content Claims are Criminal," Pollution Engineering, September 1, 2014.

The Federal Trade Commission (FTC) has stepped up its enforcement initiatives and recently settled two cases with companies that market plastic lumber and related products. FTC alleged that these companies misled consumers in violation of Section 5 of the FTC Act in their marketing materials regarding the environmental attributes of their products.

Lynn L. Bergeson, "EPA Proposes Rule to Cut Greenhouse Gas Emissions," Pollution Engineering, July 1, 2014.

On June 2, 2014, the U.S. Environmental Protection Agency (EPA) issued an ambitious and likely contentious rule to diminish significantly the United States’ contribution to greenhouse gases (GHG). The rule is proposed under the authority of the Clean Air Act (CAA) and takes direct aim at the coal industry by requiring a 30 percent reduction in carbon dioxide (CO2) emissions from existing fossil fuel-fired power plants by 2030, using 2005 as the baseline year. This column summarizes key aspects of the rule and its implications for Pollution Engineering readers.

Lynn L. Bergeson, "Notice Concerning Nanoscale Materials Remains in EPA’s Regulatory Agenda," Nanotechnology Now, June 5, 2014.

On May 23, 2014, the U.S. Environmental Protection Agency (EPA) posted its 2014 Regulatory Agenda, which still includes RIN 2070-AJ54, "Nanoscale Materials; Chemical Substances When Manufactured, Imported, or Processed as Nanoscale Materials; Reporting and Recordkeeping Requirements; Significant New Use Rule." See http://www.reginfo.gov/public/do/eAgendaViewRule?pubId=201404&RIN=2070-AJ54.

Lynn L. Bergeson, "EPA and Corps of Engineers Propose New Rule Governing Clean Water Act Jurisdiction," Pollution Engineering, June 2, 2014.

In late March, EPA and Army Corps of Engineers (Corps) proposed a rule that would dramatically revise and expand the reach of the Clean Water Act’s (CWA) jurisdiction. Unquestionably, determining the scope of the CWA’s jurisdiction, particularly over streams and tributaries, has become confusing and complex following several Supreme Court decisions and various EPA interpretations issued in response to these decisions over the years. For nearly a decade, Congress, state and local officials, industry, agriculture, environmental groups and the public have asked for a rulemaking to provide clarity. The proposal is already generating much controversy and should invite significant comments.

Kathleen M. Roberts, "How to Make Friends and Win EPA Approvals: tips for biobased chemicals," Biofuels Digest, May 28, 2014.

In last week’s Special Report on Scale-up in Industrial Biotechnology, the Digest noted that a consistent lesson shared by leading biotech heavyweights at the BIO World Congress scale-up session is to “avoid an afterthought approach to regulatory compliance.” As luck and good scheduling would have it, after lunch on the same day, savvy conference-goers got up-close-and-personal with two senior U.S. Environmental Protection Agency (EPA) regulators and a seasoned company executive involved with biobased chemicals at a session titled “Commercializing Renewable Chemicals and Biobased Products: The Importance of Successfully and Efficiently Navigating the Regulatory Process.” This article highlights the top tips for gaining EPA regulatory approval shared by EPA’s Dr. Tracy Williamson and Dr. David Widawsky at the session.

Lynn L. Bergeson, "What Can We Expect From EPA in 2014?," Chemical Processing, January 20, 2014.

This “Compliance Advisor” column outlines thoughts on what might be headed our way in 2014 from the Office of Chemical Safety and Pollution Prevention (OCSPP) of the U.S. Environmental Protection Agency (EPA). Beyond the election-driven rhetoric, demands of the discrete issues that routinely come before program management will drive the EPA. An added and complicating concern may be the impact on these and all issues of continued budget cuts that challenge the EPA's ability to operate as it has in the past; even the simple ability to process approvals or conduct public meetings about non-controversial matters have become more difficult.

Lynn L. Bergeson, "EPA Targets Significant New Use Rule-Regulating Articles," Chemical Processing, November 15, 2013.

The U.S. Environmental Protection Agency (EPA) issued in October 2013 a final rule amending a significant new use rule (SNUR) for perfluoroalkyl sulfonate (PFAS) chemical substances. The rule is receiving praise because it narrowly and precisely targets the scope of the “articles” (finished products) subject to the SNUR requirements.

Lynn L. Bergeson, "New Executive Order Issued to Improve Safety at Chemical Manufacturing Facilities," Pollution Engineering, October 1, 2013.

On Aug. 1, 2013, President Barack Obama issued Executive Order (EO) 13650, ordering federal agencies to review safety rules at chemical facilities in response to the April explosion at the West Fertilizer Co., in West, Texas. The order, Improving Chemical Facility Safety and Security, seeks to close gaps in the regulation of facilities that the government believes contributed to the fatal accident. Here is a summary of that order.

James V. Aidala, "Neonicotinoids: EPA’s New Get-Tough Measures," Law360, September 25, 2013.

Throughout 2013, the issue of the contribution of pesticide use to the decline in honeybee colony health, known as colony collapse disorder (CCD), has been increasingly controversial. Of particular concern is the role that a particular class of pesticides, known as neonicotinoids, may play in CCD. While EPA generally maintains its view that pesticides, including the neonicotinoids, are one of many factors in contributing to CCD, in July 2013, it took steps to control more stringently the foliar use of neonicotinoid pesticides, including the ones affected by the EU suspension. EPA's most recent "get tough" approach is a new labeling requirement issued Aug. 15, 2013, and available online, and it holds some additional implications. This article reviews U.S. and European regulatory developments and offers commentary on how new restrictions will affect users and applicators of neonicotinoids.

Lynn L. Bergeson, co-author, "A Multi-Stakeholder Perspective on the Use of Alternative Test Strategies for Nanomaterial Safety Assessment," ACS Nano, August 7, 2013.

This article presents the results of a January 2013 workshop convened at the California NanoSystems Institute of the University of California, Los Angeles (UCLA) and hosted by the University of California Center for the Environmental Implications of Nanotechnology, as well as the UCLA Center for Nanobiology and Predictive Toxicology. Using carbon nanotubes as a case study, national and international leaders from government, industry, and academia discussed the utility of alternative test strategies (ATS) for decision-making analyses of engineered nanomaterials (ENM). After discussions, participants generated a short list of generally shared viewpoints, including a general view that ATS approaches for ENMs can significantly benefit chemical safety analysis. The article is available for purchase online.

Lynn L. Bergeson, "EPA Wipes Away Rule; Reusable and Disposable Solvent-contaminated Wipes Get Exclusion," Chemical Processing, August 7, 2013.

As one of the U.S. Environmental Protection Agency (EPA) Administrator Gina McCarthy’s first official acts, on July 23, 2013, the Administrator signed a final rule easing the requirements under the Resource Conservation and Recovery Act (RCRA) for solvent-contaminated rags and wipes. The rule has been long in the making and much anticipated.

Lynn L. Bergeson, Kathleen M. Roberts, and Heidi B. Lewis, "Why BRAG Before You Go to Market? The Biobased and Renewable Products Advocacy Group (BRAG) Helps Companies Commercialize Their Products," Industrial Biotechnology, August 2013.

Renewable chemicals are emerging at a fast pace, paving the way for new, innovative, and sustainable biobased products. The renewable chemicals’ market is estimated to reach $83.4 billion by 2018 in applications ranging from transportation and agriculture to textiles and cosmetics. In addition to all the elements great companies need to succeed -- a great product, a great brand, inspiring leadership, and vision -- biobased product companies need to understand how the U.S. Environmental Protection Agency (EPA) occupies a virtual seat at their management table, whether or not they know it.

Lynn L. Bergeson, "The Chemical Safety Improvement Act," Pollution Engineering, August 1, 2013.

Senators David Vitter (R-LA) and the late Frank Lautenberg (D-NJ) introduced S. 1009, the Chemical Safety Improvement Act (CSIA), in May 2013. The CSIA provides a new approach to Toxic Substances Control Act (TSCA) reform that, to date, has met with broad stakeholder approval. Highlights of the draft bill are below.

Lynn L. Bergeson, "Isotope Fact Sheet Warrants a Close Look," Chemical Processing, July 10, 2013.

The U.S. Environmental Protection Agency (EPA) recently released a fact sheet (www.epa.gov/oppt/newchems/pubs/isotopes.pdf) on reporting chemical substances that contain different isotopes of the same elements listed on the Toxic Substances Control Act (TSCA) Inventory. The document has enforcement consequences, so stakeholders should review it carefully. This column explains its significance. 

Lynn L. Bergeson, "US EPA Releases Draft TSCA Chemical Risk Assessment," Environmental Quality Management, Summer 2013.

The United States Environmental Protection Agency (US EPA) released its first draft risk assessments developed under the Toxic Substances Control Act (TSCA) “Work Plan Program” on January 4, 2013. The draft risk assessments cover particular uses of five chemicals found in household products. While the chemicals covered in these first draft assessments may or may not be of interest to Environmental Quality Management readers, the draft assessments can give us a sense of how the Agency is approaching this very important process.

Lynn L. Bergeson, "Obama’s Second Term: What Does It Mean for US EPA and the Regulated Community?," Environmental Quality Management, Spring 2013.

President Obama won a decisive victory on November 6, 2012, and the forecast for the next four years is clearer now than it was pre-election. This Washington Watch column offers some preliminary observations on what lies ahead for domestic environmental management issues at the legislative and regulatory levels.

Lynn L. Bergeson, "EPA Targets Renewable Fuel Fraud," Chemical Processing, March 2013.

On February 21, 2013, the U.S. Environmental Protection Agency (EPA) proposed a new approach to assure compliance with renewable fuel volume standards and minimize fraud. The proposal offers an alternative voluntary quality assurance program (QAP) to combat fraudulently procured Renewable Identification Numbers (RINs), which have been the source of problems in the past. Comments on the proposal are due April 18, 2013. This column explains the proposal and why a new option is needed.

Lynn L. Bergeson, "Toxics Predictions," Manufacturing Today, February 12, 2013.

The U.S. Environmental Protection Agency’s (EPA) resources are not expected to be robust. This will translate to further reductions in its operating programs such as the Office of Chemical Safety and Pollution Prevention (OCSPP), and eventually (if not already) will translate into personnel, skills-mix and salary impacts. This will hinder the ability of both OCSPP programs – Office of Pesticide Programs (OPP) and Office of Pollution Prevention and Toxics (OPPT) – to review submissions in a timely fashion and meet other program objectives.

Lynn L. Bergeson, "Election Fallout: Regulatory Expectation After 2012 Election," Pollution Engineering, January 4, 2013.

Since President Obama won on November 6, the forecast for Pollution Engineering readers is a bit clearer. Below are preliminary observations on what lies ahead regarding environmental issues at the legislative and regulatory levels.

Lynn L. Bergeson, "EPA Keeps Close Eye on Cadmium," Chemical Processing, December 13, 2012.

On December 3, 2012, the U.S. Environmental Protection Agency (EPA) continued its use of the Toxic Substances Control Act (TSCA) to regulate products (not just chemicals) in publishing a final rule adding cadmium and cadmium compounds to the TSCA Section 8(d) rule. In so doing, manufacturers and importers of cadmium must submit unpublished health and safety studies to the EPA (including use in materials that have been or are "reasonably likely" to be incorporated into consumer products). This article summarizes the rule and its implications. [NOTE – on December 14, 2012, the EPA withdrew their December 3, 2012 ruling – see “EPA Withdraws TSCA Section 8(d) Cadmium Rule”] 

Lynn L. Bergeson, "The New Obama Administration: Forecast for the Speciality Chemicals Sector," Speciality Chemicals Magazine Online Edition, December 2012.

Barack Obama won a decisive victory in the presidential election on 6 November and the forecast for the next four years is clearer now than it was pre-election. This article offers some preliminary observations on what lies ahead regarding domestic chemical management issues at the legislative and regulatory levels.

Lynn L. Bergeson, "EPA Plans to Improve IRIS Process," Chemical Processing, October 25, 2012.

The Integrated Risk Information System (IRIS) database of the U.S. Environmental Protection Agency (EPA) has stirred debate for years. EPA has vowed to reform its ways, and soon may be strongly urged to do so, as a result of an underway review mandated by Congress. Specifically, the measure directs the National Research Council (NRC) of the National Academy of Sciences (NAS) to review certain IRIS assessments. This article describes IRIS and the process underway to restore IRIS dossiers to credible sources of hazard information.

Lynn L. Bergeson, "Source of Minerals Gets New Scrutiny," Chemical Processing, September 25, 2012.

On August 22, 2012, the Securities and Exchange Commission (SEC) adopted a final rule implementing Section 1502 of the Dodd-Frank Wall Street Reform and Consumer Protection Act. This important and sweeping rule is effective for products manufactured in 2013, and the first annual reports are due May 31, 2014, and on May 31 every year thereafter. It obligates companies using minerals that might have come from conflict zones to disclose their use. Because such minerals are utilized in catalysts or directly in production, the rule will impact many industrial sectors, including chemical manufacturing, electronics, paints and coatings, and automotive. Further, as the list of “conflict” minerals expands, others industries will be brought in under the scope of the rule.

Lynn L. Bergeson, "Predictions for EPA’s Office of Chemical Safety and Pollution Prevention," ABA Section of Environment, Energy, and Resources, Pesticides, Chemical Regulation, and Right-To-Know Committee Newsletter, February 2012.
Lynn L. Bergeson, co-author, "Practical Advice for Product Steward Professionals on Remaining Competent, Socially Aware, and Scientifically Proficient," BNA Daily Environment Report, January 6, 2012.

Consumer product manufacturers are challenged today as never before. Materials selection for consumer products invites a dizzying range of considerations: Are the chemicals hormone disruptors, carcinogens, or persistent, bioaccumulative, or toxic? What toxicogenomic biomarkers might make the product the next celebrity tort case? What labeling requirements apply? What are the implications of genetic variations among the demographic to which the product is to be marketed? These considerations, in turn, invite legal, marketing, and technical issues that go well beyond questions of core compliance with the law. What exactly is the professional's role? How are regional differences in regulatory standards, consumer perceptions, ingredient restrictions, and related factors to be addressed? Given the complexity of the global issues and the high stakes involved, what must a professional do to remain competent, socially aware, and scientifically proficient? This article explores these thorny questions, not to resolve them as much as to flag them, and urge professionals -- whether lawyers, product stewards, scientists, or others in the field -- to remain vigilant and as prepared as possible in recognizing the constantly shifting demands on professionals in this area.

Lynn L. Bergeson, "U.S. Wants More Transparency in Trade," Chemical Processing, June 2011.

On May 19, 2011, the Office of the U.S. Trade Representative (USTR) and the Office of Information and Regulatory Affairs (OIRA) jointly issued a memorandum to U.S. departments and agencies highlighting the importance of regulatory transparency and openness to promoting international trade. The memorandum telegraphs the Administration’s renewed emphasis on the significant role international collaboration has in domestic policy development.

James V. Aidala, "Tracking Disease Clusters and Environmental Health," Law360, April 7, 2011.

On March 29, the U.S. Senate Committee on Environment and Public Works held a hearing entitled “Oversight Hearing on Disease Clusters and Environmental Health.” Committee Chairwoman Barbara Boxer, D-Calif., and Senator Mike Crapo, R-Idaho, ranking member of the Superfund, Toxics and Environmental Health Subcommittee, introduced the Strengthening Protections for Children and Communities from Disease Clusters Act (S. 76), also known as Trevor’s Law, on Jan. 25, 2011.

Lynn L. Bergeson, "2010 Elections Could Impact EPA Programs," Chemical Processing, December 2010.

The 2010 Congressional elections will likely significantly impact policy and legislative developments in the U.S. Environmental Protection Agency's (EPA) regulation of chemicals and pesticides. The decline in the number of elected House Democratic members will make for some significant differences in EPA's budget, legislative proposals and general operations. Meanwhile, some newly elected senators stridently oppose government expansion and want to rein in federal deficit spending, which could affect the future of EPA and other government agencies.

Lynn L. Bergeson, "2011 Predictions for US Chemicals Management," Chemical Watch, February 2011.

The trends established by the Obama Administration will continue despite the Congressional mid-term elections in November.

Lynn L. Bergeson, "CPSC Moves Ahead on Harmful Products Database," Chemical Processing, November 2010.

The Consumer Product Safety Commission (CPSC) posted on its website on October 14, 2010, its draft final rule concerning the creation of a publicly available, searchable database on the safety of consumer products and other substances subject to CPSC regulation. The database is intended to provide a single point of access to reports of harm involving consumer products, manufacturer's comments on the reports, and recall information. This article discusses this important new database, and briefly considers its implications.

Lynn L. Bergeson and James V. Aidala, "How the Elections Could Impact the EPA," Law 360, November 9, 2010.

This article provides a summary outlook on possible implications of the 2010 congressional midterm elections on policy and legislative developments in the U.S. Environmental Protection Agency’s regulation of chemicals and pesticides.

Lynn L. Bergeson, "Disclosure Protection May Narrow," Chemical Processing, February 2010.

A business' ability to claim information as confidential when submitted to the U.S. Environmental Protection Agency (EPA) may soon be at risk, based on several EPA initiatives rolled out over the past year. As Congress gears up for Toxic Substances Control Act (TSCA) legislative reform, stakeholders are preparing for changes in the scope of confidential business information (CBI) protection under TSCA.

Lynn L. Bergeson, "EPA Takes Unprecedented Action," Chemical Processing, January 2010.

The U.S. Environmental Protection Agency (EPA) on December 30, 2009, issued a breathtaking series of action plans on "Risk List" chemicals that will shape future legislative proposals which industry will need to participate in and monitor.

Lynn L. Bergeson, "EPA Targets Electric Utilities," Chemical Processing, November 2009.

Approximately 5.4 million cubic yards, or 1.1 billion gallons, of coal ash from the Tennessee Valley Authority (TVA) plant near Knoxville, Tenn., in December 2008 flooded some 300 acres of land, damaging property, polluting waterways, and killing fish. TVA will likely spend more than $500 million and perhaps as much as $1 billion dollars on the cleanup, says the U.S. Environmental Protection Agency (EPA). The TVA debacle was EPA’s wake-up call for potential hazards presented by coal ash staged in some 584 units at approximately 219 domestic electric utilities.

Lynn L. Bergeson, "EPA Launches Online Discussion," Chemical Processing, October 2009.

Ever read a U.S. Environmental Protection Agency (EPA) press release and say to yourself or others, “Gee, why is EPA pursuing that matter - there are a lot of other more important enforcement priorities?” Well, now is your chance to help shape EPA’s 2011- 2013 fiscal years enforcement priorities. EPA launched an online discussion forum on August 31 to receive input on future priorities for EPA’s National Enforcement Program.

Lynn L. Bergeson, "2009 and Beyond: Outlook for Environmental Issues," Environmental Quality Management, Summer 2009.

With a new Congress in town and a new administration in charge of the U.S. Environmental Protection Agency (US EPA), 2009 promises to be an exciting and eventful year. This “Washington Watch” column provides a summary outlook on possible directional trends and developments in the regulation of key environmental issues over the coming months and years.

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